Document 171169

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HerQalife lnter~$$iqp,aI, qf jbn~rica,
1800 Century
Park East
TEL310.4.10.9600
[email protected]
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Century
x32746.
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John Venardos
Inc.
City, CA 90(!)6j-1501
FAX,310.%39J6;
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Regulatory
-,
Vice Piesident
& Government
Affairs
,
November 12.2002
Dr. Christine L. Taylor
Director, Office of Nutritional Products
Labeling and Dietary Supplements
FOOD & DRUG @$vlI.~~,T~~T~+~N
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(HFS-SOb)
1 :
5 100Paint Branch Parkway
College Park, Maryland 20740
Refi Total Control Tablets
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Dear Dr. Taylor:
Pursuantto 21 CEp 101.93,please
be advised
that Herbalife
International
of America?Inc..,hasbegun
TMDietary
supplem”eiil’
Tabl;~s~
in‘t~~‘~~l~;i”~~~~~~.
commercializing Total Control
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Total ControlTMDietary SupplementTablets are labeled and promotedwith statementsprovided
for
,r
2 in
section403(r)(6) of the FederalFood, Drug and’cdsmetic Act.
1.
LABEL
(Note: On the label, adjacent to the following copy, appears a ruled DSHEA disclaimer
BURN FAT* BLOCK
CRAVINGS*
box.)
BOOST EpERGk*
Take control of your weight with Total ControlrM, a unique herbal blend.
* Burn fat with Citrus Aurantium and Coleus*
m Feel full with Damiana*
0 Reducecravings with DL-Phenylalanineand Tyrosine”
o Boost energy with GreenTea Extract?
R Increasemetabolismw,ith Yerba”*Matf*
dt Fight free radicals with Quercetin” i I ‘- ’
That’s’Total ControITM!
2.
Total ControlTM - A Weight-Loss Revolution
Also attachedaretwo color copiesof our new Total ControiTM product brochure,titled “A Weight Loss Revolution”. Structure function claims
the brochure
,.I”. contained
s
“-2/ in
i.<~<*j,*e./”
,-.,,_
“*, i..,‘‘are
/.,*,,appropriatelyreferenced
againstruled DSHEA disclaimer~statements
eachpage where such claims are made. The structure
,,“..( “;_Ion
“!“d’
function claims containedin the attachedcolor,brochures
are very similar to those made on the product
II . .
_^._
“I a,.,
label. For example,a product fact sheetis describedbeloqas it appearson page 9. .,
HERBALIFE FACT SHEET
(Note: The asterisks appearing in the copy shown relate to the ruledDS,HEA
located on the same page of the product literature ,.as ea& stru%rre/fun$~
disclaimer box whidh is
claim;)
.
_._, (__ -. I, ’ ’
II)
O ffice of Nutritional Products
Labeling and Dietary Supplements
F O O D & DRUG ADMINISTRATION
,I, -““,.,
NovemJxr 11,2002
Page2 of 2
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Total ControlTMis,a revolutionaryherbal supplementdesignedto transformthe weight-loss process.*
This advancednon-ephe&‘fo^nnulaworks at the cellular level to*helpburn fat, block cravings and
boost energy, giving you the supportyou needto finally achieve+and
maintain your ideal weight.*
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Total ControlrM containsseveralpotent herbal ingredients,including citrus aurantium, which have
beenscientifically proven to boost the body’s resting metabolicrate and to encourage
the releaseof
.“...,
Greenor Gold Weight-Management
storedfat forenergy production.* Used,wi”th,tfi~~,~,~h~~ojetics~
Program, Total ControlrMputs you in control of s,uccessful~%eight
inanagement.”
Discussion Poip+
. Faster fat bu&ng. Citrus aurantiumhelps’iticrease’thebody’s resting metabolic rate and
promote fat burning. *
. Edatural.appetite control. Yerba mate,ia especiallyhelpful for weight-lossbecauseof its
* It also contai:nspolyphenols, which support fat
thermogenicand appetite-suppressing
properties.
I t.
metabolism.*
l
Metabolic boost. Green,teahasa natural’
“,#-it”.‘
/4alj!
tithermogemc
./J&t
a+, .. i and energy-boostingeffect.” It also
[email protected],which have beensho~~nto rnhrbrtthe,body’sfat-storing process.*
. §atiety control. DL-phenylalanine,an am& acid,“actson the brain-andcentral nervoussystemto
promote the feeling of satiety and minimije cravings.*
...LT. Feeling fuller. The herb damianapromotesappetitecontrol by slowing
the rate at which food
,
leavesthe stomach,helping you feel full longer.*
. Antioxidant boost. Quercetinis a bioflaionoid .&at helps fight free-radicalsand supports
metabolism.*
Did You Know?,
Citrus aurantmm(also known,as bitter omnge”or’zhi”ahi)is a traditional herb that has been used,for ,, ,__,__
i
thousandsof yearsin China. It has the adc&idnal
benefits
of
stimulating‘
gl;stroi;;tesli;;“‘
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*h!-:“irbs~..~
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enhancingliver function.*
Fast Facts
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Helps your body burn fat faster. *
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Helps boost your resting metabolicrate.,T
0 Controls appetite.*
o Boostsenergywithout causingirritability and restlessness,.
* _,
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o Weight-control in a single tablet. *
I_’ _/’ ‘- ’ *’ “’ ’
o Provides.antioxidant
./ ^.. ‘,,properties.
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Concentrated,easy-to-swallowtablets.
%,,L,
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. Use as part of the ThermojeticsB Greenheight-ManagementProgramor [email protected]
.
High-Protein, Low-&b Program.
Overall, product labeling and literature promineniiy bearsthe requiredruled statement, “These statements
have not been evaluated
., ,/, by the Food and Drug Administration.”This product is not intended to giagnose,
treat, cure or prevent any disease.”
Herbalife Internationalof America, Inc. certifies that the information in(,this
notice
.,-kI/_
~~~>Ai..
>,is
vi+complete
;*ii*,>gr, and
accurate,and that the compa<yflhassubstantiatioriithatthe foregoing statementsare truthful and-not
misleading.
If you have any questions,pleasedo not hesitateto
ask.
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Herbalife% Medical Advisory Board
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From the left: Jamie McManys, M.D., Lawrence Mav, M.D., Chairman, iteve %t?&ly,
M.k. “”
Mario Rosenberg, M.d., Heather Livin&bn
Thecompanywas one of the first in
the industry in the early 80s to
prides itself on &[email protected][or),
successfullyintroducea powdered
Herbalife has altiays
meal-replacement
weight-loss
product
i,:
that was‘safe and h&%d people
stayed at the lea&&
achieve
good resultswhenused as
edge of the weight-loss
directed. Herbaiife appropriately
and wellness movem$nt
namedthe productFormula1. Today,
Trrermojetjcp Formula I Protein
Drink A&?r%?ainsflerb$fe’s topsellingproductandis oneof thebestse/ling meal replacement..in the
world.
As
a
company
that
F%.d.,
andBeige,a dynamicpair of products
that blended the besf herbal
ingredientsavailablefo enhancethe
weight-lossprocess.
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Today faking advantageof recent
scientificdiscoveries
and,.outstanding
traditional herbal ingredients,
Herbalifehas formulatedthe most
advanced&eight-lossproductof its
k(nd7TotalJontror: _Th(s unique
formulais designedto burn fat block
cravings and boost energy.*
In ‘combination with Herbalife‘s
in 1992, Herbalife changed the Thermojetics Weight-Management
I ‘2 _._-a‘-,,, j * : “1 i ,.,_ ^‘ p;~gr44~s;1T;ta7 yt;-#
fa‘kes
coirrse,ofweight-losshistorywiththe
weightlossto a wholenew level.
introductionof Thermojetics”
Green
’
With adult”and
13i,,,,’ ,
_’ adolesqy$
obesify
rates in the
0 increase
* Experience
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your
Successful
weight
loss
requires fat burning, control
time to focus on innovative
r$-..
/ ~/, over cravings and improving
strategies”. metabolism. In other words,
,weight-loss
total control. That’s why
Research has shown that
Herbalife has created
..“_ Total
being overweight
i=an Contrdl’MYthe revolutionary
.
increase
your risk*, of weight-ibss formula designed
to ‘give yoc the’support you
health problems including
need to succeed once and
for
all. Total ControlTM has a
diabetes, cancer, h&H
unique non-ephedra formula
high bl6od
disease,
that contains a scientifically
pressure, stroke and even advanced blend of herbal
asthma. And new studiee.~ and nutritional ingredients
that work synergistically
for maximum, results., ,So
whether you have 10 pounds to
lose or 110, Total ConfrolTM
empowers you pound by
pound to &hi’eve’ your. goal
i
metabolism*
and maintain it.
fewer [email protected]*
Have more eflprgy*
Feel full sqqp
longer*
[email protected]
[email protected] full
0 Fight free rac#[email protected] $0 you age
graceful/y*
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indicate
that.~ being even
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“. _ _ ( ‘1-:1;.., ..sI
slightly overweight can
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rnqrease y&iihealth risks.
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* Thesestatements
havenot been~ev&?
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So take control of your good
h’ealth” by incorporating
Total
ControlTM
:-:“,,a”,d”.
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weight-loss plan.
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All these
benefits
, I. .- are
available in the convenience
of an easy-to-swallow tablet
that you take twice a day at
least 30 minutes prior to
eating a meal. Weight loss
doesn’t get any easier than
this! .Total ControlTM can help
you get the results you want
s? you not only look good,
‘but yo; feel better than ever.
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Excessweight
CanSeriously
I
7 damagey6br life
Being
overweight
affect
almost
aspect
how
can
every
of Your life, from
vou
interact
with
fami’y
and friends9
to
what kind of job you have,
,u)‘,
to how much ‘$$I
spend
in medical
Alihough
bills each Year.
see losing
weight
many
people
simply
as a way to look and feel
better, the reality is there
are
much
reasons
more
.serious
to win the batt!e
of tee bulge for life.
Losing weight
for your
health’s sake
Those who are overweight
pay a heavy price in the
health depat-tmen’t. Ex&&
weight and obesity predispose
you to several debilitating
health conditions, including:
from a heart $fack
vi dardiovascular
‘disedse,
‘.“(“^or i
diabetes, gallbladder disease, ’stroke is f$[ gre$&
gout, arthritis, asthma, many ’than sorG6AG’GYh~se
cancers and kidney disease. 1weight is‘no”&$l. .’
Worse still, obesity is the
secorid [eading cause of / ,vpying outwards, not
,‘-’
preventable deaths in th$ uipwards
: But it’S“ >bf &)ry qohr*.’
U.S. each year, claiming
300,000 lives. Aqording to physical health that can
government health, statistics, ’ suffer’ai’a G&It of‘e&+
it’s also your
obesity-related issues account ’ dounds,
,j*‘
e&“$na!
wellrb?$i
-atid’ _I
f& &pproG$eiy $i 00 b’illi?$
Receint
in healthcare
costs and ! .c&er prospects.
/
studies shpw thg,e$ent to
nearly 40 million missed
which overweight individuals we’ve create; Total ConlrolTM
workdays each year. And,
’
are
di&,riminated aghinst in -a revolutionaty weight-loss
even if you’re only moderately
workpl&e. Not only are formula designed to put you
overweight, your risk of dying the
)/1,Z!- i.i,-.“_./”2, , ,A_-,“,,,“1,” ,,,
employers less Jtkely to hrre b&i;; ‘ii‘i ‘.6Zir’?or’ *Oi ;jKtii
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‘, ti/dm&i, bui” &tistics ‘regeal
that overweight employees
j; ;,,y:;;‘;,:‘j i “;“<, ‘/, ,* -,>^ , A.;
are likely to earn IO to 20%
: .I+& ‘, ttGn‘ ., $$; .‘ it++&
iL cc$eag;es and to be given
fewer chances.foi protib’iioh.
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In “Total Cq$&MY’~~flife
[email protected] &/i&es 1,.,.”
that no dne
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*Thesestatemectshavenot
evaluated.by
“. 1 ,.,A‘, the Foodan
and iour m&a6oli&
so you
can
achieve
3.
a;,)’ _,_,, ,,and,_ _maintain
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a healthv welaht for life.”
Thanks to ;io?al ContrqlTti
-and Helbalife’i exceptio&l
fher$b.e;i;s&
. gpVh&
“”
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,M&nagKerit Programs-now
,you can lose your excess
‘pounds and enjoy all the
social, professional
and
wellness
rewards
you
:deserve!
Bitter fruit gives sweet results
A key ingredientin TotalControlTM
is
citrus aurantium-alsodalled bitter
orange or zhi shi. Although well
known as a health supplementin
traditionalChinesemedicine,it is only
recentlythat the extraordinaryvalue
of citrus aurantiumfor weight loss
hascometo light.
Total
ControlTM
a potent
blend
contains
oft t$rl$l
wh;ose
ingredients
individual
properties
work
synergistically
to opti’mize
a
the weight-loss
proc$?ss.*
We’li unlock
and
of
the scienc,e
history
these
botanicals
of
s.om$
remarkabje
and
in the following
nutrients
pages.
[email protected]$ synergy helps
accelqqt(t weight loss
In additionto citrus.aurantjum,Total
ControlTMboastsa numberof other
importantbotanicalsand nutrientsfor
weightloss,includingDL-phenylalanine,
tyrosine,coleus,damiana,greentea,
cocoa and yerba mate, plus more
than 10 additionalherbsthat support
weight managementand enhance
overallhealthand well-being.*
Lose fat without losing
your cool
Studiesshow that citrus aurantium Tea for thermogenesis
.a. .“^/”
increases the body’s resting Accordingto a studyconductedat the
metabolicrate and encouragesthe Universityof Genevain Switzerland,
release of stored fat for energy greentea hasa thermogeniceffectin
production.* What makes this thebody,increasingthe rate at which
botani$aQsq
uniqueis that it appears calories are burned.* Participants
to’increasethermogenesiswithout who were given green-tea extract
stimulating the central nervous s~~~eed~,~,s~~nificant
increasein daily
system.*As’a result‘:it ‘encourages”caloric, ex‘pend%$::.ascbmpaied .
the bodyto burn caloriesat a faster with,,the placebogroup. This study
rate without creating a feeling of koncluded that the increase in
thermogenesis
was due to the high
nervousness
or “jitters.“*
amountof catectiinspresentin green
tea. Greentea is.also knownfor its
energy-boosting
properties.*
_, t
Miraculous
mat6
For the
love’ df chocolate
As popular as coffee is in North Cacao(alsoknownas cocoa)is the
America,yerbamateis the preferred sameplant from which chocolateis
beveragein many South American made.It containsalkaloidsknownto
countries.It is enjoyedfor its abilityto support weight loss ‘in a couple
improve mood, increase mental of ways.* First, theobromine,
alertnessand help combatfatigue.* iheophyllineand small amountsof
Dietersappreciateyerbamatatea for caffeine stimu!atefat: burning and
its ability to take tha edge off “C.increase energy production.* In
Damianais an herb that has been
appetite.* It contains’
*&bstances add,itjon, cacao contains natural
shown
to slowdownthe rateat which
knownas xanthines,whichenhance mood elevators,‘“‘such
as
the stomachcontentsemptyinto the
thermogenesisand encouragefat phenylethylalanine(PEA), which
irWinal tract, therebyprolonginga
metabolism.*
Yerbamatealsoactsas createa,responsein the brain and
feelingof fullness.*In additionTotal
a mild aquaretic and provides a nervous system similar to the
ControlTMcontains.cinnamon‘bark
pleasantenergyboost.*
experienceof falling in love.*Cacao
_.. II
‘
‘
.
bhich
has been shown to support
extracthelpsdietersenjoythe moodFeeling
fuil
”
and
satisfied
‘
sugar
metabolism
and reducesugar ’
improving properties of chocolate ThreeTotalConf;oly?$
Tig;edTe.fi4nv*?h>L ,; i +&-,ri*.dsi:a*>~,m**,
,i ,x-_“<
F’,;“rl,
ri^*.”
cravrngs.
By
helprng
to fight cravings
withoutthe additionalcalories!
&d contio~~pp’
~ti~tiie,:ihese
ingrediknts
f_
enable
dieters
to
overcome
the
make
weight
loss
simple.
ty)d.. /* /”I ,. ; - 11, _ _ ::... : /, hI ,.
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problemof cravings-DC-phenylalanine
(&PA),tyrosineand damiana.*DLPA
protection
is an aminoacidthat encourages
the Antioxidant
The bioflavonoid quercetin is a
releaseof cholecystokinin(Co-a
chemicalassocrated
withfeelingfull.’ powerfulantioxidantthat is knownto
In addition,DLPAacfs~asa‘precursor supportfat metabolism.*Becauseof
to the brainchemtcaf
d$%i?he,‘$-rich hitsantihistamineproperties,it also
enhances
moodandreduceshunger.* may help reduce the stimulating
effects of caffeinefrom green tea
evenin caffeinesensitive
individuals.*
Tyrosineis also an amino acid, a
precursor to the brain chemicals
dopamine, epinephrine, and
norepinephrine.
Thesebrainchemicals
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maximumrqults.*,lt is an additional
option‘ioi’yo; ‘?o prdvide to youi
Yes,There are no state restrictions customerswho may preferthis onerelatedto TotalControl”.Thisproduct tabletoption.*
doesnot containephedra‘
ephedrine,
,
When will Total ControlTM be
ndrephedrinealkaloids.
Will Total
ContrqFM
available in Texas?
be
available in other markets?
At this timewe are reviewingtheTotal
Control””fgrm.ula,“for
acceptabilityin
is
Yes.TotalControl”will be’availablein ithey [email protected] infbrmation
available
we
iillbe
%le”to”$$
s%i?g
samplepacksof 20 packets(4 tablets
to a packet) TheVolumePointsare targetlaunchdatesin othermarkets.
37.95 andthe retailpriceis $37.95.
How do I take the product?
TheSKUis #0076.
Takeoneto twotabletstwicedaily.Take
mid-morning and mid-afternoon,
Is this product available in all
breferably
on an emptystomach.
,weight-loss programs?
What are the stock nur$nLjer, TotalControl’will
” be availablein all
Volume Points and retail’price
programs that currently include Why should I take Total
of Total ControlTM?
; 1.1 Thermgjetics”Greenand/or Original ContrSon Sn empty Stomach?
Thestocknumberis 0077.Thejloli,ime GreenandBeigeandGoldTablets,
such Ideally,TotalContr’ol”shouldbe taken
Pointsare32.95 andthe retailpriceis asGreenand&Id [email protected]?,Advanced 30 to 60 minutes befqre,meals,
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$32.95.
$3 ~l$%%~%ida’T&’ C&trolrM preferablybefore lunch and dinner.
simplepackettill’6e a%l8% in‘allIBPs. Certain ir$ebi&ts”‘ssuc~as’DLPA,
Tyrosine
andDMAEwillworkbeston an
How many tablets are ,fhere
km&
dtom&h,
whileottieringredients,
per bottle of Total [email protected],;)
IsI* Total
ControlTM
iep&ing
>,,a/.,,.,, i / ‘.. I ,* e.a,.*
in&ding GreenTea,YerbZMat6
and
Thereare90 tabletsper bottleof Total any of our current products?
Dan$a?a,
delay
gastric
(stomach)
Control”.
TotalControl’is”the nextgeneration
for
weight-losssupplemen’combining
rs,
a emptying.As a result,TotalControlTM
@$i~~czl!jr’<&&~ blind &f herbal willbe &ost effectiveif taken30 to 60
Does Total ControlTM [email protected]
ingredients
thatworksynergistically
for minutesbeforea meal.
ephedrind,
or
ephedra,
Will Total
ControlTM
be
[email protected] in sample packs?
ephedrine
alkaloids?
i !
No, TotalControl’”is a non-ephedra
product.
Can we s$l tt& prbduct
in the ephedra-rest&i‘&d
states?
Yes.TotalControi’may
” be soldin all50
states since this product does not
containephedra,
ephedrine
oreljhedrine
”
alkaloids
i ”
havenotbeen [email protected] the
Thesestatements
--T-l-T
77
7
Y-7
and
,I’_
_
,.
Total ControlTM is a revotutionaty herbal supplement
designed to transform. the-weight-loss process.*
This advanced non-ephedra formula works at the
cellular level to help burn fat, block cravings and
boost energy, giving you the support you need to
finally achieve and maintain your ideal weight:*
Total ControlTM contains several potent herbal
ingredients that help you overcome the challenges
associateGSwiJh shedding.$ounds and inches. Used
with the Thermojetics” Green Weight-Management
Program or [email protected] HPLC Program, Total
ControlTM puts you in control of successful weight
management.*
Discussion
Points
Citius auranfium helps increase the
body’s resting metabolic rate and promotes fat
burning.* And coleus, an ayurvedic herb, has active
ingredients that help generate energy to break down
fat cells.*
Natural appetite control. Yerbam @ is
especially helpful for weight loss because of its
thermogenic and appetite-suppressing
properties.*
It also contains polyphenols, which support fat
metabolism.*
Metabolic boost. Green.jeahas, a ,.natural
._. /,f/
,
thermogenic and energy-boosting effect.* It also
contains catechins, which have been shown to
inhibit the body’s fat-storing process.*
Satiety control. DL-phenylalanine, an amino acid,
acts on the brain and central nervous system to,’
promote the feeling of satiety and minimize &%ngs.*
Working synergistically with DL~phenylalanine is
tyrosine,an amino acid that is a precursor to the
brain chemicats, dopamine, epinephrine and
norepinephrine. Working together, these constituents
help reduce appetite.’
Feeling fuller. The herb darpianapromotes
appetite control by slowing the rate at which food
leaves the stomach, helping you feel full sooner
,
and longer.*
Antioxidant
boost. Quert-etinis“”a._.,..._
bioflavonoid
_...,I_” ._,,,
that helps fight free radicals and support
metabolism.*
Cit& aurantium (also
bitt,er
or zhj
, _. known
. . d.as_. ,I,
,,. orange
ii .d
shi) is a highly regarded herb thatch” been used for
thousands of years in China.’ it has the additional
benefit of stimulating’gastrointestinal
activity.
Fast Facts
~
1~ @$sy&r‘ body‘burn fat.*
n fife(ps increase your resting metabolic rate.*
1 Controls appetite.*
q Boosts energy without causing irritability
&id restlessness.*
q Weight controlin a single tablet.*
q Provides antioxidant properties:*
q I&~& part of the Therniojetics~ Green
Weight-Management
Program or Thermojetics”
q Fat burning.
q
q
q
q
q
.
,Ordering Details
90 tablets per bottle
$32,.95
#@77
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$97.35
Thermojetics” QuickStart Greim Program
If you’re ready to lose weight and keep it off, there isn’t a
Frenbh $at& #@8?0 -’ ~,~~~t;~dh6coiat~;‘
33;871
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way to do it than with :)-ler,balife’
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Tropical Fruit #3873
Thermojetics? Green or Gold/. .I#.
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QuickStart
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What is the maximum number,
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This
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advantage
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boosting
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section of www.herbafffe.com
and forwardthe Tota!ControlTM +. &od,uce TotalControlTMat your
upcoming STSs’and hand out
trainingpackageto each of your
samples.
downline.
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organizational meetings or
conferencecalls:to go over the
business opportunities-of this
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introduceyour downline to the
biggerpictureof TotalControlTM
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video, hosted by members of
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Board.
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get to -a November Success ,
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Your Total ControlTM l+ipirtg
members
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Advisory
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+ First, read and digest: the
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outstanding
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is TotalControlfM.
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lossprogramsand kits. Makeuse of
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l,i don’twork?
to buildyour-customer.ba$e.
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Tips
for
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existing customers:
to
2. Haveyou lost weight in the past
only to gain it back again plus
more?
Telephone all your existing 3. Are appetite control and food
customers and explain the
cravingsa challenge:foryou?
benefitsof this excitingproduct.
4. Do you find it dtfficultto stickto a
Sendcustomersa samplepacket
diet?
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so they can experience 5. DD you suffer from an energy
TotalControlTM
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Remember to inform your
customersthat TotalControlTM
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CorZrolTM
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tired”to avoidexercising?
availablein all Herbalife’weights
checklist:
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managementprograms.
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you wish you
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to prospects.
www.herbalife.comwhere they
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health clubs,spas,nail and hair,
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on www.herbalife.com)
to all your
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aboutthis greatnew product.
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by sendingout full productdetails
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